# K970992: Premier Nitrospray Plus and Premier Nitrospray Lite Plus

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Jun 17, 1997 after 90 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) UltraFreeze: named in the summary without a submission number
- (no number) CRY-AC and CRY-AC-3: named in the summary without a submission number
- (no number) CryoJet Model 8300: named in the summary without a submission number

## Recalls of this device
- Apr 29, 2004 · Not classified · Z-0216-05: Cryogen can escape from canister through the seal ring
- Apr 29, 2004 · Not classified · Z-0215-05: Cryogen can escape from canister through the seal ring

## Indications for use
To provide a means for transporting liquid nitrogen to the patient and to dispense the liquid nitrogen as a cold gas in a controlled manner during general or dermal cryosurgical procedures. The gaseous nitrogen, when dispensed, is at a temperature of -196°C.

Source page: https://510kreport.com/device/K970992
Methodology: https://510kreport.com/methodology